A RANDOMIZED STUDY OF QUALITY-OF-LIFE DURING MULTIPLE RISK FACTOR INTERVENTION IN TREATED HYPERTENSIVE MEN AT HIGH CARDIOVASCULAR RISK

Objective: To examine the effect on qualify of life in hypertensive me n of a multiple risk factor intervention programme compared with that of usual care. Design: A prospective, open, randomized, parallel-group study with allocation either to a comprehensive multiple risk factor modification programme or to usual care. Setting: An outpatient clinic in a city hospital. Patients: Five hundred and eight treated hyperten sive men, aged 50-72 years, with at least one of the following: serum cholesterol greater than or equal to 6.5 mmol/l, smoking habit or diab etes mellitus. Intervention: Nutritional advice, behavioural treatment principles and drug therapy. Main outcome measures: Minor symptoms ev aluation profile (MSEP) was used to measure change in quality of life. Results: The intervention programme led to sustained effects on lifes tyle-related variables such as hypercholesterolaemia, body mass index and smoking habits, whereas diastolic blood pressure and HbA1(c), rema ined unchanged. The change in the MSEP during follow-up did not differ between the intervention and the usual care groups. There was a close relationship between the measurements of the three MSEP dimensions at baseline and at follow-up (P < 0.0001). None of the potential risk fa ctors measured at entry was significantly associated with change in th e three MSEP dimensions during follow-up. Conclusion: The multiple ris k factor intervention programme directed towards smoking habits, hyper cholesterolaemia and the metabolic control of diabetes mellitus in tre ated hypertensive men at high cardiovascular risk was not associated w ith an impaired quality of life compared with that in a control group. The method used, the MSEP, has previously been found to be a reliable method with good validity, and this study's results provide further e vidence of its validity.